Effectiveness, safety, and methotrexate dose-tapering pattern over two years of treatment with adalimumab and >= 12 mg/week methotrexate for early rheumatoid arthritis: Results of the HAWK postmarketing surveillance study in Japan

摘要

Objectives: To investigate the long-term effectiveness, safety, and methotrexate (MTX) dose-tapering patterns in patients with rheumatoid arthritis (RA) receiving adalimumab plus high-dose MTX. Methods: In this prospective, postmarketing study (2012-2017), conducted at 128 sites in Japan, biologic-naive patients with RA (duration = 3 months, initiated treatment with adalimumab and MTX (>= 12 mg/week). Effectiveness by Disease Activity Score in 28 joints using C-reactive protein (DAS28-CRP), safety, and MTX dose-tapering were assessed from baseline to 104 weeks. Results: In the effectiveness analysis set (n = 292), DAS28-CRP remission ( = 12 mg/week reduced to 52.9% (n = 82/155) by week 104. Per univariate regression analysis, MTX dose tapering was associated with longer adalimumab drug survival. Of 70 patients with joint X-rays available, 59 (84.3%) achieved Delta modified total Sharp score <= 1.0 at 104 weeks. In the safety analysis set (n = 300), 143 adverse drug reactions were reported in 92 patients (30.7%, non-serious; 24.7%, serious 8.7%). Conclusion: The long-term effectiveness and safety of adalimumab with high-dose MTX was confirmed in biologic-naive patients with early RA in a real-world setting in Japan.